Effects of Overload Progressive in the Treatment of Shoulder

Shoulder Impingement Syndrome Clinical Trial

Official title:

Effects of Overload Progressive in the Treatment of Shoulder Impingement Syndrome Associated With Scapular Dyskinesis: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02870257
• Other study ID #: 1.487.198
• Status: Completed
• Phase: N/A
• First received: August 4, 2016
• Last updated: October 9, 2017
• Start date: August 2016
• Est. completion date: July 2017

Study information

• Verified date: October 2017
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Seventy subjects with shoulder impingement syndrome associated with scapular dyskinesis will be recruited and randomized into two groups of treatment. The group "a" will receive a strenghtening protocol with progressive overload during 20 sessions and group "b" will receive the same protocol with minimal load, without change during the 20 sessions. The primary outcomes measures will be pain, function, quality of life, global impression of recovery. The change will be measure from baseline at 10 weeks (after 20 sessions), 3 and 6 months (follow-up). The secundary outcomes will be disability, quality of life measure by other instruments, shoulder muscle strength and scapular 3d kinematic variables. For these data, change will be measure from baseline at 10 weeks (after 20 sessions).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

Inclusion Criteria:

• People with diagnosis shoulder impingement syndrome or supraspinatus/rotator cuff tendinopathy or subacromial bursitis

• shoulder pain for more than 4 months, at least 4 points of pain in 0-10 NPRS

• at least 130° shoulder active elevation

• 3 or more positive of 5 physical examination tests (painful arc, external rotation resistence, Neer, empty can (Jobe) and Hawkins-Kennedy

• positive dynamic scapular dyskinesis in clinical observation

Exclusion Criteria:

• Referred pain from vertebral spine

• previous shoulder, elbow or neck surgery

• complete rotator cuff tear (positive drop arm sign or substantial shoulder elevation or rotation weakness)

• neoplastic or neurological disorders

• previous fracture or dislocation injury (shoulder, humerus, clavicle)

• adhesive capsulitis signs

• inflammatory diseases

• specific treatment for the shoulder in the previous four months (injection, physiotherapy)

• using drugs in the previous week

• inability to understand portuguese language

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome
• Syndrome

Intervention

Other:
• Strengthening protocol with progressive load
Strengthening protocol for scapular and shoulder muscles
• Strengthening protocol without progressive load
Strengthening protocol for scapular and shoulder muscles

Locations

Country	Name	City	State
Brazil	UNINOVE	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Numeric pain rating scale (0-10)		baseline, 10 weeks, 3 months and 6 months
Primary	Change in SPADI (Shoulder Pain and Disability Index) Questionnaire (0-100)		baseline, 10 weeks, 3 months and 6 months
Primary	Change in ASES (American Shoulder and Elbow Surgeons) Questionnaire (0-100)		baseline, 10 weeks, 3 months and 6 months
Secondary	Disabilities	DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire (0-100)	Change from baseline at 10 weeks
Secondary	Quality of life	WORC (The Western Ontario Rotator Cuff Index) Questionnaire (0-100)	Change from baseline at 10 weeks
Secondary	Muscle Strength	Shoulder internal rotation, external rotation, adduction and abduction muscles measured by handheld dynamometer	Change from baseline at 10 weeks
Secondary	Scapular kinematic	3D data of scapula at 30, 60, 90 and 120° of shoulder abduction	Change from baseline at 10 weeks
Secondary	Global impression of recovery	GPE (global perceived effect) scale (-5 to +5)	Change from baseline at 10 weeks, 3 months and 6 months